Litigators abhor a vacuum. After more than a decade of legal uncertainty about a fundamental and squirm-inducing question—should DNA, the recipe for life and death, be patentable?—a trio of University of Toronto law school alumni working pro bono are forcing a court to rule on a subject long neglected by Parliament. Possibly many lives and certainly a lot of dollars hinge on how judges will adapt patent law to the world of the double helix.

In 1991, a team of scientists linked a particular snippet of DNA to a heart disease that causes otherwise healthy teenagers to drop dead. In 1997, they received a first American patent for their detective work, and before long they had patented enough genes associated with the disease to create a niche market providing a test for diagnosis. The disease is called Long QT Syndrome (LQTS), and it affects about one in every four thousand people, whose hearts take slightly too long to recharge between beats. This leads to fainting and seizures, and, in 10 to 15 percent of cases, sudden death.

An LQTS test for a Canadian costs about $4,800, a tab paid by our government and pocketed by American corporations. If a doctor orders the test for you, they take a blood sample, courier it to an American lab in Maryland or Connecticut, and get an answer four to eight weeks later. Performing the test in Canada would be cheaper and faster, but it would also violate gene patents.

Sana Halwani '04

This may be about to change, if U of T law school alums Sana Halwani, JD 2004, and Nathaniel Lipkus, JD/MBA 2006, have their way. “This case is an extreme example of patents gone wrong,” Halwani says. She and Lipkus, of Gilbert’s LLP, are representing the Children’s Hospital of Eastern Ontario (CHEO) in federal court litigation and seeking to invalidate or avoid the LQTS gene patents.

“The core position,” says their client Alex Munter, president and CEO of the Ottawa-based CHEO, “is that no one should be able to patent human DNA. It would be like patenting water or air.”

Lipkus grapples with what he calls the fundamental “tug of war” in patent law between accessibility and innovation. He wanted to figure out how to incentivize the provision of AIDS medications to poor parts of the world, so he travelled to Thailand in 2004 to investigate new models for private-public partnerships in drug development. He would later publish a paper about his research that concluded: “As a society, we cannot afford to misuse the scarce funds available for the innovation of new drugs for neglected diseases.” Now, as then, Lipkus is more concerned with practical impact than with moral problems. “At the end of the day, you need to find the balance that makes people money and makes sick people better,” he says.

As for Halwani, she comes equipped with an undergraduate degree in biochemistry and graduate school research in England about access to reproductive technologies. When she clerked for Supreme Court Justice Rosalie Silberman Abella, LLB 1970, the Court heard an important pharmaceutical case, AstraZeneca Canada Inc. v Canada (Minister of Health).

Five years ago, CHEO tried to perform their own LQTS tests for their patients, and Ontario’s Ministry of Health promptly received a cease and desist letter from American patent owners. The government relented.

Now, doctors and researchers fear a new and larger roadblock. The age of “whole genome sequencing” has arrived, which means we will be able to affordably test many or even all of our 20,000 or so genes at the same time. For those who have seen the ’90s film Gattaca, a futuristic thriller in which genes are destiny, whole genome sequencing will be like the procedure that pinpoints the protagonist Ethan Hawke’s genetic weaknesses, but hopefully minus the dystopia.

The trouble, however, is that individual gene patents may prevent the whole genome test from ever coming to fruition. Alternatively, as CHEO chief of genetics Dr. Gail Graham explains, if a lab technician finds out during a whole genome test that a patient has a genetic problem, it is not clear the technician will be at liberty to report the problem without violating the gene patent.

For a hospital, this is a nightmare scenario. “Our doctors and scientists simply cannot accept the prospect of a child dying…because a patent prevented us from diagnosing and treating a serious life-threatening condition,” Graham said at a press conference. “Genetics is poised to make major advances that will allow us to more rapidly provide life-saving diagnoses and treatments. Continued patenting of DNA will stop us from fully realizing that potential.”

The statement of claim Halwani and Lipkus submitted last November argues that naturally occurring genes are not patentable, and even if they are, next-generation sequencing would not violate individual gene patents.

Richard Gold '88

Richard Gold, LLB 1988, a leading Canadian scholar on gene patents who teaches at McGill University’s Faculty of Law, is also offering advice on policy and international context for the CHEO case. “There has been a non-partisan ignoring of the issue in Canada,” he says. “It seems a court case is the only way to get answers.” Gold has argued that many individual gene patents are overly broad and will hamstring the innovation promised by whole genome sequencing. As things stand, “[t]he uncertainty is getting in the way of Canadian health care,” he wrote recently in The Globe and Mail.

Most people know about gene patents because of actress Angelina Jolie. In 2013 she very publicly opted for a double mastectomy after a pricey gene test revealed that she carried a genetic mutation associated with a high risk of breast cancer, BRCA1. But this is just the most famous example of a vast new frontier of genetic research and “personalized medicine.” As of 2013, there were 15,359 patents on genetic sequences in the United States, ground zero for the commercialization of the genome, and in Canada about 2,000 patent applications have been submitted.

Where there are patents, there are lawyers. Thus far, globally speaking, our fickle lady the common law cannot make up her mind about patents and genes. The United States Supreme Court recently ruled that genes cannot be patented. Australia’s Federal Court recently went the other way. This pair of American and Australian cases involved the same pharmaceutical company, Myriad Genetics, and the same genes, the ones that Angelina Jolie found swirling in her cells.

In 2013, the United States Supreme Court unanimously ruled in Association for Molecular Pathology et al. v. Myriad Genetics that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” The stock price of Myriad Genetics dropped five percent the day the judgment was released. “Myriad did not create anything,” Justice Clarence Thomas wrote for the court. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.” Patent eligibility required more than “[g]roundbreaking, innovative or even brilliant discovery.” The price for the test swiftly fell to $1,500, down from about $4,000.

Last September, in D’Arcy v Myriad Genetics Inc, on similar facts involving the same company’s patent for the same genes, the Federal Court of Australia diverged from the American approach and upheld the patents for gene mutations associated with breast cancer. The unanimous court wrote that the “isolated nucleic acid…has resulted in an artificially created state of affairs for economic benefit.” Discovering and isolating was invention enough to warrant a patent, the court reasoned. (The lawyers representing Yvonne D’Arcy have applied for special leave to appeal.)

Nathaniel Lipkus '06

For its part, the European Union allows gene patents, with significant caveats and exceptions. The European approach is guided by legislation by the European Parliament that took over a decade to craft and pass. In 2001, the European Court of Justice considered a challenge to the law, but the court ruled that patenting genetic material that was isolated from the human body is not a contravention of the principle of the right to human dignity.

Now it is Canada’s turn to draw a line. Back in 2001, Ontario Premier Mike Harris insisted that gene testing for breast cancer be performed in Canadian hospitals and funded by provincial health-care plans in a bid to save health care from monopoly pricing, even if this meant flagrantly violating patents. He insisted—in a nod to his communist supporters, no doubt—that “[o]ur genetic heritage belongs to everyone. We must share its benefits fairly and do what we can to make genetic tests and therapies affordable and accessible.”

Harris urged the federal government to make rules to tame what he called the “Wild West” of gene patenting. His fellow premiers joined him in demanding federal action. In 2002, the eminent Romanow Report on Canadian health care also recommended a review of how patent law dealt with gene patents. Yet none of these gadflies managed to stir a somnolent Parliament.

Over a decade later, a court will now fill the void. One of the barriers to litigation was cost, but Halwani and Lipkus are volunteering their advocacy pro bono. They estimate the case will cost their firm in the vicinity of two million dollars in foregone fees. “There is no moneyed interest on our side,” Halwani says. “But it feels like right thing to do, because we’re trying to allow clinicians to provide the best level of care to their patients. This is a real problem and we are trying to provide a real solution. And we need courts to weigh in, because right now there is no certainty whatsoever.”

As it happens, the University of Toronto may have something to lose if its alumni win the case. A corporation called HSC Research and Development Ltd, which houses commercialized research at SickKids Hospital, owns some patents for the breast cancer-related genes and is a named party claiming damages in ongoing American litigation to enforce gene patents.

Thus far, the defendants in the Canadian LQTS case—Genzyme Genetics, the University of Utah Research Foundation, and Yale University—have not yet submitted their statements of defense, nor did they make themselves available for comment. In the meantime, the lawsuit has already sparked national and international headlines.

“I don’t see this as a moral case,” Lipkus says. “A lot of people do. I see it as a practical case, a case that will improve access to health care and improve innovation. That is the best outcome to generate as a patent litigator.”